Outline of a Research Proposal

Publishing study protocols do benefits the research community from the following perspectives. First, full and unbiased reporting of prespecified analysis is essential for the credibility of research and the care of patients. Therefore, protocol is encouraged to increase transparency by making more information available than required by registries. Second, by enabling readers to readily visit a study’s protocol, helping to increase the reporting accuracy and to make internal and external validity clearer. Third, protocol review giving others the opportunity to see and understand deviations that may occur during the study and this will help the investigators to improve the quality of the study design. Lastly, accessible protocols will also help future researchers in the field to design better trials and prevent unnecessary duplication work.

1. Topic

The title should be concise and informative about the research question. Avoid use of extraneous words such as "study," "investigation," etc.

2. Abstract

A summary of the proposed study

3. Literature review

a. Comprehensive understanding of the subject and background

b. Cite and discuss systematic reviews that have been reported on the topic, otherwise conduct a ‘mini’ or a sufficient literature review

c. Know what has been published

d. What issues or controversies remain

e. Thorough and comprehensive coverage of the issue- the conceptual framework

4. Problem statement

a. Show concise understanding and the important of the research question to answer with testable hypothesis.

b. State the expected outcomes and benefits; results that have potential impact to the current primary care practice.

5. Objectives

Clear and measurable general and specific objectives

6. Methods: Theoretical design

a. Focused research question with clearly conceptualised and operationalised measurable variables;

b. Feasible, important and interesting, novel, ethical and relevant

7. Methods: Data collection design

a. Inclusion and exclusion criteria for participants

b. Clearly defined setting

c. Valid and reliable measurement or measuring tools

d. Appropriate sampling method (representativeness/comparability)- highest possible validity, lowest risk of biases with respect to available resources and existing constraints

e. Study flow chart

8. Methods: Data analyses design

a. Sample size estimation

b. Appropriate choice of intended statistical tests

c. Explain how missing data will be handled

d. To justify decision to dichotomise any continuous data at certain cut-points, sub-group analysis or sensitive analyses

e. Dummy tables

9. Discussion

Show anticipatory thoughtfulness of possible shortfalls and limitations of the study and means to mitigate them. Point out the efforts and strength of the study where validity is maximised

10. Conclusion

Highlight the relevance and importance of the proposed research topic or research question. Reiterate the feasible, highest possible validity and precision of the proposed methodology

11. Budget

Outline a reasonable expenditure to be expected

12. Gantt Chart and other related appendices

Depict the progress of the study from beginning to the end

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